Levetiracetam Hospira (levetiracetam)
- Region
- 🇪🇺 EU
- Active substance
- levetiracetam
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Epilepsy
- CHMP opinion
- Wed 23 Oct 2013
- EU approval
- Tue 07 Jan 2014
- Designations
- Generic
- Application
- EMEA/H/C/002783
- ATC
- N03AX14
- Official record
- www.ema.europa.eu
Indication
Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam Hospira is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Keppra Authorised · UCB Pharma SA
- 🇪🇺 Levetiracetam Actavis Authorised · Actavis Group PTC ehf
- 🇪🇺 Levetiracetam Teva Authorised · Teva B.V.
- 🇪🇺 Levetiracetam ratiopharm Authorised · ratiopharm GmbH
- 🇪🇺 Levetiracetam Actavis Group Authorised · Actavis Group PTC ehf
- 🇪🇺 Matever Authorised · Pharmathen S.A.
- 🇪🇺 Levetiracetam Sun Authorised · Sun Pharmaceutical Industries Europe B.V.
- 🇪🇺 Levetiracetam Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Epixram Application withdrawn · Neuraxpharm Pharmaceuticals S.L.
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